MAUDE Adverse Event Report: MEDTRONIC NEUROSURGERY VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM ANTIBIOTIC; CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)

Catalog Number	50318
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	03/17/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was unavailable for return as it was discarded at the facility.Therefore an evaluation of the device performance was not possible.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported to medtronic neurosurgery that a physician stated the catheter broke off during a procedure during insertion.According to the report, the catheter popped off/snapped while in the patient during the procedure.Reportedly, the patient experienced pneumocephalus.Per the surgeon, the current status of the patient was fine and they had returned to baseline.
Additional Manufacturer Narrative
Additional information received reported that due to the catheter breaking, the surgeon was delayed in relieving the intracranial pressure of the brain and the patient developed pneumocephalus.According to the report, a different manufacturer¿s catheter was used.It was noted that some breakage happened after the catheter had been sutured in the ventricles of the patient¿s brain.
Additional Manufacturer Narrative
Additional information received reported that no unintended section of the catheter remained inside of the patient's body and no additional procedures were required due to the reported event.This reported event is 1 of 3 similar events.Please refer to manufacturer reports #2021898-2017-00222 and #2021898-2017-00223 for details regarding the other two events.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: VENTRICLEAR II VENTRICULAR DRAINAGE CATHETER SET WITH COOK SPECTRUM ANTIBIOTIC
• Common Device Name: CATHETER, VENTRICULAR (CONTAINING ANTIBIOTIC OR ANTIMICROBIAL AGENTS)
• Manufacturer (Section D): MEDTRONIC NEUROSURGERY; 125 cremona drive; goleta CA 93117
• MDR Report Key: 6514826
• Report Number: 2021898-2017-00224
• Device Sequence Number: 18860922
• Product Code: NHC
• UDI-Device Identifier: 10827002441306
• UDI-Public: 10827002441306
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K071640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 03/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2018
• Device Catalogue Number: 50318
• Device Lot Number: 7025160
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided; 05/22/2017
• Initial Report FDA Received Date: 04/22/2017
• Supplement Report FDA Received Date: 05/25/2017; 06/01/2017; 10/03/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 24 YR